Hip, hip, EUA.
That could be Regeneron Pharmaceuticals’ reaction to the news on Saturday about their product REGEN-CoV2, the antibody cocktail that U.S. President Donald Trump received when he had Covid-19. This combination of casirivimab and imdevimab has now received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to treat mild to moderate Covid-19 in people who are 12 years and older and at least 40 kg in weight. Forty kilograms is about four-fifths the weight of an octopus in case you are wondering.
Casirivimab and imdevimab may seem like great words for Scrabble when you stuck with a bunch of “v’s” and “i’s” and want something besides the Coldplay song “Viva la Vida.” But they are also recombinant human IgG1 monoclonal antibodies. The word “recombinant” comes from “recombine,” as in recombining genetic material in different ways in the laboratory to produce new types of antibodies. Antibodies are proteins that can bind and potentially neutralize specific proteins such as those that are part of an invading virus.
In this case, the proteins that casirivimab and imdevimab target are the spikes on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The virus looks like a very, very small spiky massage ball. If someone tries to massage you with a Covid-19 coronavirus, leave the spa immediately. The spikes on the SARS-CoV2 aren’t supposed to make you feel good. Instead they are naughty spikes, helping the virus get into your cells to infect them, sort of like a crow bar to get into a locked cabinet that has toilet paper rolls in it. So antibodies binding these spikes may be able to then keep the SARS-CoV2 from getting into your cells.
It is the second antibody therapy for Covid-19 that has received an EUA from the FDA. Earlier this month, the FDA granted Eli Lilly and Company an EUA for bamlanivimab.
Neither REGEN-CoV2 nor bamlanivimab is meant to be a “cure” for Covid-19, despite Trump calling REGEN-CoV2 that after he received the treatment at Walter Reed Medical Center. A study published in Science showed that REGN-COV2 was able to substantially reduce the amount of virus and some of the effects of the virus in rhesus macaques and hamsters infected with SARS-CoV2. If you happen to not be a hamster, Regeneron released some of the findings from human trials of REGN-CoV2 at the end of September that showed that those who received the treatment ended up having lower viral loads and fewer subsequent medical visits.
A EUA doesn’t mean that the treatment has been approved. It doesn’t mean that you will soon be seeing REGEN-CoV2 television commercials of people dancing in grassy fields in slow motion. It means that during an emergency, which is what the Covid-19 coronavirus pandemic is, the FDA has determined that in certain situations the potential benefits of casirivimab and imdevimab may outweigh the risks.
Again it’s important to remember that REGEN-CoV2 is not a cure for Covid-19 and is not a fully approved treatment. It is something that could potentially, possibly in some cases reduce the chances of mild-to-moderate Covid-19 progressing to more severe Covid-19. However, don’t start forgoing social distancing, face mask use, and other precautions because you somehow think REGEN-CoV2 can rescue you in case you get infected with the SARS-CoV2.
Moreover, REGEN-CoV2 may not be the most affordable treatment. Trump could get the treatment because he was on a government insurance plan, one that’s not available to most people. Sure, Trump has claimed that he will make REGEN-CoV2 “free” for all Americans. Nevertheless, don’t bank on the treatment being free until you actually see it happen.